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Verapamil effect on refractory epilepsy treatment

Not Applicable
Conditions
epilepsy.
Localization-related (focal)(partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures
Registration Number
IRCT2012121711778N1
Lead Sponsor
Shiraz University of Medical Science
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
20
Inclusion Criteria

- Male/female patients, aged 18 and above.
- Diagnosis of epilepsy made on the basis of clinical and EEG findings.
- Refractory epilepsy is defined as failure of two or more AEDs at maximal tolerated doses and 2 or more seizures per month.
- There have been no more than 4 weeks between seizures over the 2 months prior to entry to the study.
- Having stable medication regimen for 8 weeks prior to entry.
- Patient is male or a non-pregnant female adequately protected from conception.
- Informed consent by patients or their families/care givers.
Exclusion criteria:
- Patient has a progressive neurological condition.
- Patient has a history of non-compliance for seizure diary completion or frequent clinic visits.
- Patient is pregnant at the time of enrolment.
- Patient has any serious medical illness or major psychiatric disorder, history of psudoseizure, or history of suicidal attempt in the past 5 years.
- Patient has any contraindication for verapamil administration including:
severe GI narrowing, heart failure, hypertrophic cardiomyopathy, cardiac conduction disturbances, hypotension, hepatic impairment, renal impairment, and known history of hypersensitivity to verapamil.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Seizure frequency. Timepoint: monthly. Method of measurement: questionnaire and check list.;Seizure quality. Timepoint: monthly. Method of measurement: questionnaire and check list.
Secondary Outcome Measures
NameTimeMethod
Blood pressure. Timepoint: one week after starting Verapamil, one week after titrating Verapamil, and then monthly. Method of measurement: Digital blood pressure monitor.;Pulse rate. Timepoint: one week after starting Verapamil, one week after titrating Verapamil, and then monthly. Method of measurement: counting manually.
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